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The Stryker Spine OASYS® System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The Stryker Spine OASYS® System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The Stryker Spine OASYS® System can be linked to the Xia® System, SR90D System and Xia® 4.5 Spinal System via the rod-to-rod connectors and transition rods.

The Stryker Spine OASYS® System can also be linked to the polyaxial screws of the Xia® II and Xia® 3 Systems via the saddle connector.

The Stryker Spine OASYS® System is comprised of rods, polyaxial screws, bone screws, hooks, connectors, and occiput plates. The components are available in a variety of lengths in order to accommodate patient anatomy. The components are fabricated from Titanium alloy and CP Titanium and are provided non-sterile. The subject system also offers Vitallium® rods. The Stryker Spine OASYS® System can be linked to the Stryker Spine Xia® family and Xia 4.5 Systems and SR90D System.

The purpose of this submission is to expand the use of the OASYS® System to include the use of screws in the posterior cervical spine.

The provided text is a 510(k) summary for the Stryker OASYS® System, a spinal fixation device. It outlines the device's indications for use, technological characteristics, and a summary of performance data. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria for a new AI/software-based medical device study.

Therefore, most of the requested information regarding acceptance criteria, specific study design details like sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating AI or software devices, cannot be found in this document.

However, I can extract the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document does not specify quantitative acceptance criteria in the typical sense for an AI/software device (e.g., sensitivity, specificity thresholds). Instead, it relies on demonstrating substantial equivalence through mechanical testing and comparison with predicate devices.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable. This is a medical device for spinal fixation, and the "test set" refers to mechanical testing of the physical device, not an AI model's dataset. The document does not provide sample sizes for the mechanical tests, nor does it refer to data provenance in the context of clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable. This is a physical medical device. "Ground truth" in this context would implicitly refer to established engineering standards for mechanical strength and durability. Expertise is inherent in the design, manufacturing, and testing process against these standards, but the document does not specify a number of experts for "ground truth" establishment in the way it would for clinical AI validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This is a physical medical device. Mechanical testing results are objective measurements against established standards, not subject to human adjudication methods like those used for expert consensus in clinical image interpretation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This document pertains to a physical spinal fixation system, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or software-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" for the performance of this physical device is based on established engineering standards (ASTM F1717 & F1798) for mechanical testing (static/dynamic compression bending; static/dynamic torsion) and the characteristics of legally marketed predicate devices by which substantial equivalence is claimed.

8. The sample size for the training set:

Not applicable. There is no concept of a "training set" for this type of physical medical device in the context of an AI/software study.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set mentioned or implied for this physical medical device.

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